Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

We are seeking a Senior Manager, Clinical Affairs to lead strategic initiatives within our Advanced Patient Monitoring (APM) portfolio, a cornerstone of our mission to improve patient outcomes through cutting-edge technology. In this role, you will oversee a high-performing clinical operations team, ensuring the successful design, execution, and monitoring of clinical trials that support regulatory compliance and product excellence.

You will play a pivotal role in shaping clinical strategies for IDE, NSR IDE, and post-market studies, while fostering collaboration across R&D, Regulatory Affairs, Clinical Affairs, and Key Opinion Leaders. This position demands a visionary leader with deep expertise in clinical operations, exceptional project management skills, and the ability to influence change across a global organization. If you are passionate about advancing patient care through innovative monitoring solutions and thrive in a fast-paced, cross-functional environment, we invite you to bring your expertise and leadership to our team.

Job responsibilities:

• Manage and oversee the work of a clinical operations team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department. Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs
• Oversee the planning of start-up activities (e.g., protocols, informed consents, contracts, scope of work, case report form development, training materials) with accountability for successful completion within scope of project deliverables. Maintain high level continuity of materials developed and ensure alignment with internal and external stakeholder needs (e.g., R&D, RA, Clinical Affairs, KOLs)
• Provide strategic direction on field and remote monitoring of studies and data collection for all clinical trials, act as a study project manager, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial  documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Lead in the identification and evaluation of alignment opportunities to standardized processes across the organization and lead the implementation of course correction
• Identify and mitigate risks due to multiple competing timeline assessments

Experience and Education required:

• Bachelor’s degree in related sciences field.
• 8 years progressive experience in medical device clinical trial design, planning and execution.
• 5 years experience with hands-on clinical research monitoring.
• 3 years of proven experience in direct people management, including coaching, mentoring, and developing high-performing teams to achieve organizational goals.

Knowledge and Skills required:

• Proven strategic planning skills for IDE, NSR IDE, post-market medical device studies
• Proven successful project management skills with meticulous attention to detail
• Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP)
• Exceptional written and verbal communication skills, with strong interpersonal abilities including negotiation and relationship management to drive objectives
• Expert-level knowledge of clinical operations procedures, with the ability to resolve complex, cross-functional issues and influence outcomes beyond the immediate team.
• Extensive knowledge of human anatomy and physiology
• Exceptional problem-solving, organizational, analytical, and critical thinking abilities, with a proven track record of delivering innovative solutions.
• Strong leadership skills with the ability to